Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

OIG INSPECTION INTO CRAWFORD'S DEPARTURE CONTINUES

The HHS Office of Inspector General (OIG) continues
to investigate the circumstances surrounding the resignation of former FDA commissioner
Lester Crawford, according to a recent correspondence from the OIG to lawmakers.

"As our inquiry remains active and ongoing at this time, no conclusions
have been reached," Inspector General Daniel Levinson wrote in a recent
letter to Rep. Maurice Hinchey (D-N.Y.). "Our review will examine all leads
as they continue to be developed."

The OIG launched an investigation into Crawford's resignation in October at
the request of Hinchey and several other House Democrats, as well as a request
from a bipartisan Senate group that included Sens. Michael Enzi (R-Wyo.) and
Edward Kennedy (D-Mass.). The lawmakers told the OIG they were particularly
interested in determining whether Crawford left the agency because of a potential
financial conflict of interest.

Crawford abruptly left the agency in September, only months after being confirmed,
leading lawmakers to question his motives. Crawford had also been under fire
for his role in delaying a decision over whether to sell the Plan B contraceptive
over the counter. This move led to charges that the decision was politically
motivated, a charge that was later substantiated by a Government Accountability
Office report.